A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in Pre-treated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
Patients with pre-treated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were docetaxel 30 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (\>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
800 mg/m2, CIV (CIV.in the vein) on day 1\~5 of each 28 day cycle.
15 mg/m2, IV (in the vein) on day 1\~4 of each 28 day cycle.
・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting.
Time frame: 1 year
Determine the clinical response rate of patients in Phase I setting.
Time frame: 1-year
Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting.
Time frame: 2-years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.